3 services found
Ascendia Pharmaceuticals Services
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Development - Timing
Saving time during every stage of the drug development process is a critical factor. Saving time can mean the difference between being first to market for a new class of drug, or for a first-to-file generic. This is especially important during early development when important decisions have to be made between competing developmental programs. Ascendia recognizes the value of rapid development timelines, and offers services designed to reach early-stage key milestones in your development program quickly. Our services include pre-formulation, enabling formulations for toxicology and pharmacokinetic studies, pilot ANDA formulations, and Phase I clinical trial materials for either oral or parenteral products.
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Pre-Formulation Data Package Services
Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated. During the pre-formulation phase, the physical and chemical properties of the active pharmaceutical ingredient (API) are determined. The knowledge gained on the API helps to select the right salt or polymorphic form, and supports the design and development of an initial dosage form, both for pre-clinical and clinical use. Ascendia’s ...
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Small-Scale Formulations Services For Pre-Clinical Testing
Ascendia develops and evaluates a variety of formulations for preclinical non-GLP and GLP studies. We understand the needs of companies with an exciting compound in the discovery pipeline, but with limited amounts of drug substance. We have developed methods for carrying out formulation screening studies with as little as several mg of drug substance. These methodologies can be used to formulate new drugs for initial in vivo experiments when only low ...
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Rapid Development Through Phase I CTM
Ascendia works with discovery-stage pharmaceutical companies to provide lab-scale formulations suitable for pre-clinical testing. We conduct pre-formulation assessments, bioavailability modeling, and formulation approach comparisons. We provide trial formulations suitable for animal studies, toxicology studies, and cGMP clinical trial materials for Phase I studies. At Ascendia, our core business is to develop practical, customized product formulations for ...